Covance by Labcorp is seeking candidates for a Clinical Data Manager II within Medical Device and Diagnostics. The Clinical Data Manager II can be remotely located anywhere within the United States. In reference to Minneapolis, MN, candidates can be remotely located in the role or office based in Minneapolis, MN adhering to pending office re-entry guidelines due to pandemic related-restrictions.
Participates in all aspects of data management under supervision. Implements, manages and maintains clinical databases and related study software.
- Under supervision, participates in aspects of data management including, but not limited to:
- Designing CRF's, CRF completion guidelines, database user requirements, technical requirements;
- Creating data management plans;
- Performing data entry, ongoing data review, medical coding, e.g., of adverse events, medical history; or concomitant medications;
- Coordinating and facilitating User Acceptance Testing (UAT);
- Reviewing protocol and clinical study reports for data management content;
- Creating and maintaining tools for efficient management of the project;
- Creating or reviewing all other data management-related study documents and validation efforts;
- Overseeing data validation efforts, including plan and report generation, staff training, validation oversight and corrections.
- Managing study records related to Data Management responsibilities for the Trial Master File.
- May develop, validate and maintain databases in accordance with customer and regulatory requirements
- Recommends solutions to internal project teams and clientele as necessary.
- May interpret and implement 21 CFR, Part 11 requirements.
- Assists in establishing and maintaining Clinical Trial Management (CTMS) and/or electronic regulatory binder features and functionality and new module features and functionality (e.g., safety, adjudication, device accountability, monitoring) standardization.
- Develops and maintains project timelines and budgets and reports any issues to project manager.
- Analyzes and reports all study issues to supervisor, project manager, and/or sponsor, as appropriate.
- Works with Biostatisticians and clinical project managers to define reports, edit checks, new database features, etc.
- May interact with Biostatisticians and clinical project managers to further Covance by Lapcorp's use of database features and modules.
- May serve as database user expert.
- Complies with Covance by Labcorp and applicable sponsor SOPs.
- Assists in the creation and management of internal training, data standardization and/or SOPs.
- Participates in client meetings, as necessary.
- Science, IS (information systems), health-related, or technical Bachelor's degree.
- Minimum of three years of data management and/or clinical experience preferred with at least two specifically in data management.
- Excellent communication and interpersonal skills.
- Strong organizational skills.
- Ability to travel up to 20% time preferred.
- Experience with clinical systems, including data management, EDC, and Clinical Trial Management Systems (CTMS) experience is required.
- Ideal EDC experience includes MedNet, IBM Clinical, Medidata Rave, and/or Veeva.
- Medical Device and/or diagnostics experience is preferred.
- Database development and/or validation experience is preferred.
- Experience with MS Office and at least a basic understanding of software capabilities and business applications.
- Ability to independently handle multiple tasks and prioritize with minimal
- Understands the importance of building and maintaining client relationships and providing excellence in service delivery.
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